Recall Z-0043-2017
Trumpf Medical Systems, Inc. · initiated July 10, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material Number 1604786 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system
Codes / lots: Serial Numbers - 101863316, 101872464, 101879109, 101880571, 101880672, 101880673, 101928935, 101932527, 101937343, 101941055, 101941064, 101941995, 101942798, 101948309, 101954296, 102051758, 102061764, 101926753, 101928934, 101941978, 101941994
Reason for recall
Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.
FDA-determined cause: Nonconforming Material/Component
Action taken
Trumpf Medical sent an Urgent Field Safety Notice dated July 8, 2015, to all affected consignees. The letter indicated that the tables should not be used until an authorized service engineer has exchanged the spindles of the affected operating tables. The letter included an acknowledgement form which is to be returned. The letter also requested a sub-recall if the product had been further distributed. For questions regarding this recall call 843-329-0543.
Details
- Recall number
- Z-0043-2017
- Initiated
- July 10, 2016
- Posted by FDA
- October 5, 2016
- Terminated
- March 2, 2017
- Product code
- JEA – Table, Surgical With Orthopedic Accessories, Ac-Powered
- Quantity
- 84 units
- Distribution
- Worldwide Distribution - US including CA, CT, GA, IL, NC, OR, SC, VA, WI, WY, and Internationally to Australia, Azerbaijan, Brazil, Finland, France, Germany, Hungary, Italy, Luxembourg, Norway, Poland, Russia, Slovakia, and Switzerland
- Recalling firm
- Trumpf Medical Systems, Inc., Charleston, SC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0040-2017 Class II | Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5500…Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters. | 07/10/2016Terminated |
| Z-0041-2017 Class II | Stationary Column TruSystem 7599, Material Number 1717020 Patient positioning during…Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters. | 07/10/2016Terminated |
| Z-0042-2017 Class II | Floor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Column ARTIS…Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters. | 07/10/2016Terminated |